AIIMS ICU Rehabilitation (AIR): development and description of intervention for home rehabilitation of chronically ill tracheostomized patients

Background The paucity of state-supported rehabilitation for chronically ill patients with long-term tracheostomies has ramifications of prolonged hospital-stay, increased burden on acute-care resources, and nosocomial infections. Few interventions describe home rehabilitation of adult tracheostomized patients. Almost none involve stakeholders. This paper describes the All-India Institute of Medical Sciences (AIIMS) ICU rehabilitation (AIR) healthcare intervention developed to facilitate home rehabilitation of chronically ill tracheostomized patients. Methods The AIR intervention development was based on the experience-based codesign theory (EBCD). A core research-committee studied prevalent knowledge and gaps in the area. Patients-carer and health-care stakeholders’ experiences of barriers and facilitators to home care resulted in an intervention with interlinked components: family-carer training, equipment bank, m-health application, and follow-up, guided by the Medical Research Council (MRC) framework. Healthcare stakeholders (doctors, nurses, medical equipment vendors) and patient-carer dyads were engaged to gather experiences at various stages to form smaller codesign teams for each component. Multiple codesign meetings iteratively allowed refinement of the intervention over one year. The Template for Intervention Description and Replication (TIDieR) checklist was used to report the AIR intervention. Results The first component comprised a minimum of three bedside hands-on training sessions for carers relating to tracheostomy suction, catheter care, monitoring oxygenation, enteral feeding, skincare, and physiotherapy, buttressed by pictorial-books and videos embedded in a mobile-application. The second was an equipment-bank involving a rental-retrieval model. The third component was a novel m-health tool for two-way communication with the core group and community of other patient-carers in the project for follow-up and troubleshooting. Home visits on days 7 and 21 post-discharge assessed patient hygiene, nutrition, physiotherapy, and established contact with the nearest primary healthcare facility for the future. Conclusions Findings support the EBCD-based development using active feedback from stakeholders. Assessment of feasibility, process and effectiveness evaluation will follow.


Methods
The AIR intervention development was based on the experiencebased codesign theory (EBCD).A core research-committee studied prevalent knowledge and gaps in the area.Patients-carer and healthcare stakeholders' experiences of barriers and facilitators to home care resulted in an intervention with interlinked components: familycarer training, equipment bank, m-health application, and follow-up,

Introduction
With improved life support systems, acute illness is increasingly associated with patients surviving long stays in intensive care units (ICUs), prolonged hospitalization in post-acute (weaning) centres, and poor prognosis in the long term 1 .These patients who have survived a period of acute illness, but are not yet free from life sustaining therapies are referred to as the chronic critically ill (CCI).The incidence of chronic critical illness has doubled in recent decades and may double again in the next decade 2 .
Consensus definition for CCI combines two factors: care received in the ICU for at least eight days, and at least one out of five eligible conditions (prolonged mechanical ventilation (MV); tracheostomy; sepsis; severe wounds and/or multiple organ failure; ischemic stroke, intracerebral haemorrhage or traumatic brain injury) 2 .Prolonged need for mechanical ventilation due to cardiopulmonary disease, inability to protect the airway due to neurological dysfunction or brain injury are the main reasons for tracheostomy in the CCI.
Since these patients are often bedridden, tracheostomized and oxygen or ventilator dependent, they require trained caregivers (CGs) for daily care such as enteral feeding, catheter care and physiotherapy.There has emerged an unmet need for adequate rehabilitative opportunities for CCI patients worldwide.In developed healthcare systems, such patients are cared for by state-delivered healthcare services-professional CGs or in nursing homes.This has a dual benefit: for the hospital, it means clearing up resources for the acutely ill, and for the patient, it means returning to familiar surroundings and a reduced risk of hospital-acquired infections.These benefits of out of hospital rehabilitation are often not available in Low Middle-Income Counties (LMICs) where state-delivered rehabilitation systems are less well established.The entire burden (physical, psychological and economical) of care often falls on family members of the patient.
The implications and outcomes (including cost) following protracted ICU stay are potentially devastating for patients and their families.Reasons for this include limited availability of and access to rehabilitation services, lower baseline health literacy, concomitant infections in the presence of antibiotic resistance, and spiralling financial burden associated with healthcare costs and loss of income.
For patients at risk of extended ICU stay and CCI, discharge home to be with family is a priority.Not only does timely discharge alleviate the burden of the cost of hospital care, but it may also reduce the incidence of healthcare associated infections (HCAIs) and provide families opportunities to be at home with their loved ones as they attempt to recover.
Although some teams from India [3][4][5] South Africa 6,7 , and Thailand 8 have recognized that family members of chronically critically ill tracheostomized patients can be trained to accept and successfully execute home rehabilitation, the attempts have been sporadic 5 , tailored for paediatric population 6 , and even unsuccessful at times 9 .Causes put forth are a lack of specific training, education and support for family CGs (hereon referred to as carers) in the form of assistive devices and timely referral to health services [10][11][12][13] .
To meet this gap in Odisha, a state in Eastern India, a team of critical care physicians, nurses, rehabilitation specialists, and dieticians from the All-India Institute of Medical Sciences (AIIMS) designed an intervention to facilitate home rehabilitation of tracheostomized CCI patients.The endeavour was supported by the National Health Mission Odisha and Collaboration for Research, Training, and Implementation in Critical Care in Asia and Africa (CCAA)-a Wellcome Trust Innovations project.
The AIIMS ICU rehabilitation (AIR) project has designed an intervention that will empower and equip family carers to accept and execute home rehabilitation of chronically ill tracheostomized patients.In many instances, interventions are poorly described regarding the training material, the number of sessions, duration, dose, intensity and mode of training delivered 14 .A detailed description of the key components of an intervention makes it easier for other researchers to replicate the intervention in clinical settings and research 15 .

Methods
The AIR intervention is a bundle of four components: i) Hands-on training of carers, ii) an m-Health app providing information and two-way communication via voice, message, and audio between patient-carers and the health care team, iii) an equipment bank, and iv) post-discharge home visits and telephone follow-up that are threaded together by processes of patient-carer selection and counselling for inclusion.
The initial development and piloting of the AIR project broadly followed experience-based codesign (EBCD) method that enables service users and providers to work collaboratively to improve care in an iterative, reflexive manner driven by stakeholders' experiences 16 .We also based our development on guidelines by MRC and O'Cathlain 17,18 .The methodology and results are reported as suggested 'actions' and 'potential outputs' structured by the latter 18 .The timeline and steps of development of the intervention are summarized in Figure 1.

Planning the development process
Study Site.AIIMS Bhubaneswar is a 900 bedded tertiary care teaching center having 100 adult ICU beds.The ICUs are managed by different departments, with most patients in this study being

Amendments from Version 2
In this version of the manuscript, we have added greater details to better describe the Mobile Application component of the intervention and modified language in some places as suggested by the reviewer.
Any further responses from the reviewers can be found at the end of the article AIIMS conducts more than 15,000 surgeries requiring an inpatient stay.At any point, > 5% of inpatients are extended-stay-patients, with a length of stay > 21 days.These patients most commonly belong to neurosurgery, neurology, general medicine, and emergency-trauma departments.
Identifying the problem.ST,JM,BR,UH, all intensive care physicians, noting repeated readmissions of tracheostomised patients discharged from the ICU due to hospital acquired infections, conducted an audit of hospital length of stay of inpatients.The results demonstrated unusually protracted lengths of stay for adult tracheostomised in comparison to non-tracheostomised patients.

Assessment of priority and obtaining resources.
Informal feedback from treating physicians, nursing staff and patient families indicated that the problem of being unable to discharge tracheostomised patients out of the hospital due to complex issues (unavailability of long-stay healthcare centres that accepted tracheostomy patients, inability of families to afford the few facilities that were available and fear among family members to care for these patients at home) was substantial.All stakeholders including hospital administration agreed on the priority of an intervention that would encourage family led timely discharge of these patients.A period of 2 years was considered adequate to develop and pilot such an intervention and the institute leadership endorsed funding application to the National Health Mission for financial support.
Bringing together a team and establishing a decision making process.To investigate this problem in greater details, we formed a research team (RT) consisting of doctors and nurses (later joined by project staff : research assistant RA, Nurse Trainer NT, Psychologist P, and Field worker FW).The RT reviewed the existing literature regarding home care for tracheostomy patients 11,[19][20][21][22][23][24] and their carers 5,25 .Data from resource-limited settings were limited, and concurrent research was undertaken to understand the caregiver burden for homedischarged tracheostomy patients in the local set-up 26 .We next formed a core committee (CC) that included, along with the RT, representatives of key technical members of the institute (information and technology I&T and Finance), the funding agency, and an institute staff with experience of repeated ICU admissions as the patient representative (PR).The CC was responsible for reflecting on evidence, identifying wider stakeholders, and overseeing the project.The organogram in Figure 2 elaborates on the roles of the CC.
Involving stakeholders.The RT formed a Patient Representative Group (PRG) of five previously discharged tracheostomised patient-carer dyads.Next, they mapped health care workers (HCWs) from ICU and allied specialties and non-HCW individuals likely to be involved in the patient care pathway (such as equipment providers and m-health app developers) into Working Groups (WGs).Selected members of the CC led each WG.This provided an opportunity for members of the wider multidisciplinary teams involved in the care of critically ill patients and representatives from non-medical disciplines to be involved in the design and implementation of the components of the AIR project.The WGs' inputs resulted from engaging with the CC and sharing experiences through interviews and focus group discussions.
Weekly meetings of leads of different WGs, principal investigator, and members of the CC not a part of the RT were held to allow reflexivity in the process.In addition to the engagement exercises, we disseminated information about the interventionposters were put up in relevant areas of the hospital, and academic presentations were made to doctors, nurses, and trainees.
During consent taking, a four-page handout in Odia or English was given to carers.Copies were displayed at each nursing station.A video of 10 minutes duration (in Odia, English, and Hindi) prepared by the RT was available to inform the patientcarer and clinical staff about the project to engage illiterate, visually challenged, or those who preferred to 'see' than read the detailed written information.The video was shareable with extended family via WhatsApp when carers needed to discuss participation in the project.Videos of members of the PRG taken during engagement exercises were shown, and eligible participants were encouraged to contact previous recruits for clarifications.Details of materials designed for stakeholder engagement are described below in results.

Review of published research evidence.
A review of literature was undertaken before and during the intervention development process to identify existing interventions and study published intervention development approaches.A realist review was undertaken towards the later end of the development to understand the barriers and facilitators of intervention implementation to help understand the context and possible need for adaptations in the design or processes.PROSPERO registration ID-CRD42022347389 Developing a programme theory.Iterative steps of literature review and discussions within the RT, CC and PRG helped articulate a programme theory at the beginning of development.
A LOGIC model was drawn to tie the findings from literature review and stakeholder experience to planned activities and intended outcomes of the intervention.(Figure 3) This diagram was refined through the development and used to communicate intervention components with team members and external stakeholders.
Undertaking primary data collection.The research team transcribed and analysed field notes and transcripts captured during the PRG and WG meetings.Analysis was undertaken by RT members (ST, APS, NKP, SM, UP, and AKS) using an interpretive analysis approach.The findings from different sources were triangulated to identify overarching themes and discussed with the whole CC.The critical needs identified were translated into the following interlinked interventions: training modules, m-health application, equipment bank, and post-discharge follow-up, which are described in detail in the results section.
Designing and refinement of the healthcare intervention.
The AIR intervention was planned to be a bundle of components: i) Hands-on training of carers, ii) an m-Health app providing information and two-way communication via voice, message, and audio between patient-carers and the health care team, iii) an equipment bank, and iv) post-discharge home visits and telephone follow-up.The screening and training process, equipment bank, and m-health app development began by December 2020.The home visits began after August 2021 due to COVID-19 disruptions (Figure 1).Refining was informed by multiple meetings with the patient-carers, the WGs, and the CC to make iterative changes in the intervention design and take feedback on the changes implemented.Project staff telephonically and during home visits collected lived experiences from carers after home discharge.The CC formed WhatsApp groups among themselves, WGs, carers, and PRGs to engage multidisciplinary teams and allow collaborative, self-conscious criticism and appraisal of the context and subjectivity of the RT members.WhatsApp groups and the m-Health app were actively used for exchanging information, photographs, audio and video messages, suggestions, and feedback among project members-CC, WG, and Carers.One such iteration led to RT members collecting direct feedback from carers in 'exit meetings' at hospital discharge.(Figure 3).The details of iterations are detailed in results.
Stakeholder engagement.Members of the CC convened for every patient-carer dyad who returned for a change of indwelling catheters or decannulation to applaud their efforts.For HCWs, the photographs and the appreciative messages that the patients and carers sent from home on WhatsApp and mHealth chats were shared with the ICU team and referring doctors.Patientcarer dyads were invited to the ICU to meet with HCW teams on follow-up hospital visits.WG meetings moved to Zoom platform in response to the infection control practices implemented as part of the COVID-19 management.Two 'celebration events' was organized at 70 th recruitment that marked end of development and on the 200 th pilot recruitment, where 40 patient-carer dyads and 60 HCWs and members of the Institute and Funding agency participated.

Intended sample size
Learning and data from the first seventy patient carer dyads and other stakeholders (doctors, nurses, project staff) was used to finalise the iterations and adaptations of the intervention.Patients and families were recruited for thereafter for the pilot evaluation.

Ethics
The institutional ethical review board of AIIMS Bhubaneswar (Registration number ECR/534/Inst/OD/2014/RR20) granted ethical approval for studies informing the AIR intervention development process in AIIMS Bhubaneswar (Ref T/EMF/ Anesth/20/53) dated 24/10/2020.All carers and patients were explained the project aims and written consent taken for elective participation, use of information sheets and photographs for academic non-commercial use.

Results (Outputs)
The intervention was named AIR, an acronym for AIIMS ICU Rehabilitation.

Findings from literature review and codesign exercises.
International efforts at tailoring healthcare to the unique needs of long-term tracheostomized patients with or without mechanical ventilation 11,22,27,28 have involved multi-professional teams that coordinate regionally adapted training initiated at the tertiary-care centers and continued across healthcare sectors.Interpretation of the lived experiences of the five family patient dyads of the PRG revealed that the current care pathway for patients discharged home was disturbing for the patient and the family.Dyads reported physiological and emotional distress: "the hole in the neck is alarming" and "my neighbours will get scared when they see the hole".Beyond the psychological and physical factors, we identified five sub-themes associated with the care pathway.These were, i, fear of caring for the airway and tracheostomy itself, ii, inability to ensure adequate nutritional intake for the patient, iii, concerns over costs and out-of-pocket expenditure related to hiring/purchase of equipment, iv, fear and helplessness while making unsupervised urgent decisions at home, v, insecurity over leaving the hospital sans a medical guardian.For healthcare providers, three themes emerged: i, lack of time for dedicated counselling or training of carers, ii, poor coordination of discharge pathways with clinical pressure for ICU beds versus logistic readiness for discharge, iii, doubts over carer ability to provide safe home-care within financial and logistic constraints.
Team building and characteristics.The CC conducted interview-based recruitment for the RA, the NT, FW, and the P.
The RA was trained in biotechnology with prior experience in clinical work.The counselor was a trained psychologist, the NT a trained ICU nurse, and the FW trained pharmacist and paramedic.Each of these team members had more than two years of experience in their field and had successfully collaborated on similar service improvement projects in the healthcare system in the region.Further details of the roles appear in Figure 4.The CC and the RA conducted the departmental and project induction, including good clinical practice (GCP) training.The CC members ensured further integration into the hospital.Each had good spoken and written English, Odia, and Hindi.
The Equipment vendors and m-Health application experts were selected by an open call and meeting with the CC.Potential vendors were screened for track record and asked to tender quotations reviewed by the CC and assessed for adherence to the AIIMS service tender requirements.
Design of intervention components.The findings of the interpretative analysis were disseminated back to the CC and combined with findings of review of the literature to explore how home care/discharge packages could be used to inform the design of the AIR intervention.Themes i and ii (lack of confidence with care procedures) directly led to the development of the training component of the intervention.The CC identified ten key components of daily care: catheter care, tracheostomy care, suctioning, monitoring oxygenation, home ventilation, enteral feeding, blood sugar management, bowel, and bladder care, handling common emergencies, and nutrition awareness.
Regarding theme iii (concerns over costs), it directly led to the decision to make available standard equipment and consumables, requisite information, and readily available troubleshooting (suction machines, oxygen concentrators, home ventilators, pulse oximeters, glucometers, hospital bed/backrest, airbed, suction catheters, gloves, gauze, betadine, tracheostomy tubes, indwelling catheters).Themes iv, v (fear and insecurity) led to a digital solution that would provide ongoing support and communication between the healthcare team and the patient/ family and post-discharge home visits and telephonic follow-ups.The CC recommended that the digital app would need to include training videos and curated 'Frequently Asked Questions' to provide an on-demand resource tool to support carers in the direct delivery of care at home.Suggestions for loading training videos into the application came from PRGs 'training steps get forgotten with time, and videos or pictures will remind the carer'.One PRG member suggested that building a community chat option in the mHealth application will enable sharing of stories among carers and provide psychological support.I&T expert, S&P personnel, PR, and CC discussions in the WG meetings codesigned the specifications for the mHealth app and agreed that a rental model of equipment procurement and handing over would best fit the requirements expressed by the PRGs.Data entry.The research personnel were trained in eCRF data entry over a series of 3 sessions with online support from trainers from the CCAA.Study data were collected and managed using an E-CRF (REDCap electronic data capture tools) hosted at AIIMS Bhubaneswar 30 .

Training of Team
The AIR intervention (Figure 4) Patient-carer recruitment Screening.Nurses in charge of clinical areas catering to tracheostomised patients (three ICUs, five high dependency units, and an emergency area) identified patients to a designated CC member.The RA screened patients.Eligibility for inclusion was -adult patients admitted to the ICU and tracheostomised, with a likelihood of surviving to hospital discharge, dependent on carers for activities of daily living such as enteral feeding, urinary catheter, bed, and bowel care.Those who were hemodynamically unstable, on high ventilatory, or requiring high oxygen support (>50%) at the assessment time were followed up every alternate day.Patients who had a tracheostomy solely for relieving airway obstruction and were otherwise independent were excluded.Patients who had no known relatives or if the relatives were incapacitated were excluded.The parent clinical team discussed the likelihood of survival beyond hospital discharge.
Counselling.Once eligible, the psychologist (P) approached the patient and carer for consent and explained the aims of the AIR intervention using the support materials described in Checklist Item 3 below.Carers who were unsure were scheduled for a follow-up interview with a member of the CC and the treating physician.It was explained that the decision not to participate would not impact ongoing care.After consent, the Nurse Trainer (NT) assessed patient physiology for bedside training and began hands-on training using the materials described in item 3 of the TIDieR below.

Intervention Bundles
Carer training.(tracheostomy management, nutrition, and personal care (prevention of pressure injury, catheter care, promotion of muscle/movement).Each carer was explained the need for the procedures (training modules) and then demonstrated the correct steps.Subsequent sessions were a mix of hand holding and independent demonstration of the modules by the carers.The number of training sessions required depended on the carers' experience and attitude and could vary from a minimum of 2 to 6 sessions, each lasting for 30-45 minutes.The training was individually adapted and provided in groups of two participants supervised by the trainer.Some family members who had more significant difficulties in learning were invited to watch other families who had achieved greater confidence or were in more advanced training sessions.
To assess training readiness, the carer was asked to score his confidence subjectively before and after each module at each session on a numeric scale of 0-10, where 0 was 'not confident at all' and 10 was 'very confident, can teach others'.When their scores reached 8 or more in a module, an objective assessment for technical performance was done by the NT on a score sheet developed by the CC.A score of > 8 on subjective confidence and >5 on objective performance was considered adequate to declare the carer 'adequately trained' in a module.
The M-Health application.The application was kept simple and user friendly.Each patient carer dyad was supported with downloading from Playstore and creating a login id and password if requested.Pictorial icons were used liberally to allow less literate users easy navigation.The different sections were: I. Patient and carer data, including discharge note-this information was a quick aid for FW to remember the diagnosis and ongoing medications at discharge, and for the carers to present to other HCWs if needed.II.Chat feature, for patient carers to communicate with the RT (discussions between one patient carer dyad and any member of the RT were not visible to other patient-carer dyad) III.Community chat for patient carers to communicate among each other (comments being visible to all members),IV Guides-PDF documents in 3 languages detailing common procedures V. FAQ section that had curated questions and answers for common trouble shooting, this list grew in real time as new queries arose.VI Videos This section had a selection of trainings captured in real time to remind the carers of each step of the different procedures.The application was loaded on the carers' mobile in the project room.They were trained in its use.The carers were encouraged to see the training videos, read the guides, and interact with the team to increase their confidence in post-discharge support.The key components and processes involved in AIR app delivery, training, and usage for enabling timely discharge, education and communication of patient and family carers after home discharge appear in Figure 5.
Equipment handover and set up.One to two days before discharge, equipment vendors were invited to hand over the appropriate equipment and train the carers in the use and troubleshooting.A toolkit of daily-need consumables for 3-4 days was provided.The kit contains a head end-elevation support, an airbed, reusable gloves, suction catheters, 100ml saline bottles, gauze, chlorhexidine hand wash, an extra tracheostomy tube with heat-moisture filter, and an AMBU bag (purchased directly, not rental) was handed to the carer.The project covered equipment rental costs for one month for all patients: extendable at the discretion of the CC.The head end-elevation support, air bed, and AMBU bags were to be returned once the patient recovered or expired for cleaning and reuse.The consumables and equipment were handed over two days predischarge.The family members were explained (and infographic given) that the equipment was NOT free: that they are being handed over as a gesture of support for a maximum of one month until patient recovery or death and for buying time for the family to procure them if needed longer.ID proof was retained until the equipment is returned to be used by another family.
The project Field worker (FW) discussed the layout of the carers' home via photographs sent over the mobile.Patient placement after reaching home was agreed upon before discharge.An exit meeting with P and an RT member before discharge enabled carers to ask questions and the RT to get feedback and experiences.
Home visit and follow-up.Daily telephonic contact for the first three days by the NT was followed by FW-initiated follow-ups on days 7,14,21, and 28.The patient's quality of life and career burden was assessed with the EuroQOL 5D (EQ5D-3L) and Caregivers Burden Scale (CBS) on days 7 and 14.Nutrition status and risk assessment were done on all follow-ups by the patient-generated subjective global assessment short form (PG SGA) tool, 24-hour recall of dietary nutrition, and a survey to assess the barriers and facilitators of providing enteral nutrition to tracheostomy patients.Based on the feedback, a CC member and dietician-guided telephonic counselling was done for patients at high risk for malnutrition.Physical home visits began on days seven and 21 midways as an iterative modification based on feedback received in Carer Meeting 2. (Figure 1) Location of Intervention.Induction and obtaining consent were done in face-to-face meetings.Although an attempt was made to have all the meetings in a designated space-the 'project room', the research assistant and psychologist were free to choose any quiet space where speaking to family members would be convenient.Training sessions were always given at the patient's bedside after confirming with the treating nurse.Exit interviews with ICU faculty were in a designated office room with facilities for audio-visual display; persistent questions and remaining fears were addressed.Follow up at days 14 and 21 were telephonic, on video calls, or at hospital visits (if the patient had returned for assessment with the parent department).Home visits were made on days 7 and 28 after discharge.
Figure 4 details the procedures, activities, and processes used in the intervention

Informational materials used in the intervention delivery A. To introduce and advertise the project
• Poster: a one-page poster was designed to succinctly highlight the 'Who', 'Why', 'Where', and 'How' of the intervention.Benefits anticipated for the healthcare system and patient-family were mentioned.
Along with the contact number of project personnel, the names of all core committee members, including intensivists, neurosurgeons, nursing, physiotherapy psychologist, and research assistant, were printed to enable easy reach out for patients and hospital personnel.This poster (English and Odia versions) was put up in various areas of the hospital (wards, casualty, and OPD).The goal was to get health care workers (HCWs), administrators, and patientfamilies curious.(Underlying data 1) • Brochure: a more detailed brochure in four pages (coloured, with representative photographs) was designed as patient-family handouts.The goal was to give the patient family a better understanding of its components and goals.(Underlying data 2) • Video: a video, 10 minutes in duration (in Odia, Bengali, and Hindi), was available to inform patientfamily about the project.
• Consent form: the consent form had an information sheet attached to it.

B. For training carers
• Printed modules: step-by-step advice for caring for tracheostomy, oral and tracheostomy suctioning, bed care, nasogastric feeding, care of indwelling urinary catheter, monitoring blood sugar with a handheld device, and administering insulin, using a pulse oximeter, and bathing the patient was bundled into a booklet.The process was iterative, requiring three revisions that catered to carer suggestions, doubts, and queries before the final draft.
(Underlying data 3) • Training videos: after collecting feedback from the first 25 patient-carer sets, we learned that the TT suctioning, nasogastric feeding, and bathing were most daunting for carers.With the feedback received, videos were prepared to show 'real-world' procedures being done, in one case by a real patient-carer (the patient bathing video).
• Assessment modules: to help the trainer assess the progress in training and increase self-confidence among the carers in patient care, a multidisciplinary team decided on a subjective self-assessment tool (Likert scale based) to be administered to the carer before and after each training session.A score sheet was created based on must-demonstrate, and good-to demonstrate skills for each module to help the trainer recognize the requirement for further training sessions.It was observed in the course of intervention design that some carers appeared very confident but were unable to demonstrate safe patient care adequately; therefore, two-pronged feedback was planned: -Self-assessment tools that mapped the improvement in carer (trainee) self-confidence over each session and the entire training period.
-Objective assessment by the trainer of hands-on bedside patient care skills on the final day of training (when the carer self-confidence in each module is 8/10 or greater).(Underlying data 4 28 ) • Subjective global assessment of carer attitude, aptitude, and preparedness for home care by two faculty of the project team, not involved in training.
• Physical training in the use of equipment: hands-on training on equipment was provided to carers 1-2 days before planned patient discharge.Dietary guide sheets: printed guides were given to the patients based on needs assessed by a dietician.

Dose and Intensity of Intervention.
AIR was delivered from patient identification and consent to one month after patient is declared fit for discharge from the hospital.Contact with the patients and family carers continued until patient death or recovery as they retain access to the mobile application and protect the team's contact details.The initial scouting was rapid, taking about 10 minutes, followed by an assessment and counselling session that lasted approximately 45 minutes.
Bedside training sessions took between 45 minutes to one hour for the first session; subsequent sessions took between Worries about equipment safety and retrieval subsided, and vendors agreed to new terms of supply.

Hands-on training of carer
One-on-one training.One family at a time.Minimum 3 sessions.
Carers with significant difficulties in learning were invited to watch ongoing sessions of more confident carers or those in more advanced stages.
Peer learning and watching other carers perform was an incentive that improved acceptance.

Videos of common procedures
The first iteration had videos filmed in simulated settings Conflicts in or changed final-carer status were not uncommon: all stakeholders agreed that the other three limbs of the app would help home rehabilitation.
30 to 45 minutes each.A minimum of three sessions were provided; sessions were given until the carers' subjective confidence in each module improved to >8 and objective scores given by the trainer were >5.The field worker spent at least 2 hours with the patient, retraining the carers at the home visits on days 7 and 21.The psychologist spent 10-20 minutes in the follow-up calls scheduled on days 1-3, 14, and 28.
Tailoring of the intervention and modifications.Modifications were informed by identifying the experiences, distress, needs, and preferences for support by families looking after chronically ill patients with tracheostomies in situ. 6,8,27,29,30.
• Five relatives (one husband, three sons, and one wife) of tracheostomized patients previously rehabilitated home and were involved as family-carer research partners.Demonstrating videos of previously rehabilitated patients and enabling contact of ongoing patients with them via telephone or community chat option in the mobile application helped in closer community networking.
A clinical psychologist was involved as an expert research partner,and research group members worked collaboratively throughout the study.Data were analysed iteratively using written summaries of the workshops parallel to data collection.
• Patient carers were given a choice of attending the initial assessment and counselling sessions via telephone, face to face at bedside/project room or cafeteria to allow for comfort and flexibility.
• All dietary and nutrition advice was tailored to local Odia cuisine segregated based on seasonal availability and cost.
As the intervention was being developed iteratively, adaptations, titrations, and personalisation were an ongoing process.
To date, the adaptions introduced are presented in Table 1.

Eligibility for free equipment
Patients and carers below the poverty line (having 'BPL' status (Below Poverty Line)) could avail the free Equipment bank A one-month free facility for all patients: followed by a consideration based on a case-to-case basis.
The family members were explained (and infographic given) that the equipment is NOT free: they are being handed over as a gesture of support for a maximum of two months until patient recovery or death and buying time for the family to procure them if needed longer.
Providing equipment free initially improved acceptance.

Discussion
We describe the development and details of a multicomponent intervention to facilitate carer-led home discharge for tracheostomy patients.In its mature form, the AIR intervention engages stakeholders from the initiation of patient recruitment to home discharge and follow up in a way that hopes to empower families to care for their tracheostomised bed ridden patients at home, by using the four components of the intervention: the hands-on training for carer confidence, the equipment bank allowing for facilitated home discharge in our economically challenged population, the mHealth app allowing bidirectional communication and home visits for continuation of support.
Intervention development is dynamic, iterative, open to change and forward looking.Among the different guidelines for development of complex healthcare interventions, advise and suggested frameworks differ 18,[31][32][33] .We used the target population centred approach to development, as we were very focused on the problems faced by this particular patient population (tracheostomised and bedridden) in the context of problems faced in the healthcare system of a low middle income country like ours 31 .Although we incorporated all components of the TIDieR Framework 14 for detailed description of the intervention, O'Cathains guidance was valuable in simplifying the structure for reporting the development and describing the components in detail.
While all development approaches emphasize on stakeholder inclusion and engagement, we found that in our cohort, carers (predominantly female, elderly, or less educated) had difficulty recognizing home-rehabilitation as a process: accepting a top-down approach rather than suggesting changes and following the orders of health care teams came more naturally.These challenges to codesigning exercises are known in developing countries 34 , and triggers such as analogies, showing pre-recorded videos of previous carers relating their experiences, and one-on-one meetings with CC members or project staff led to richer discussions in our population than meetings with more stakeholders.Scheduling meetings at a time and place of choice of the stakeholder-whether patient-carer or WGs or other HCWs worked best.Greater carer focus on 'free equipment' compared to getting trained had to be circumvented with a conditional approach: the equipment would be given only when patient-care skills are demonstrated.The one-month rental policy with keeping an identity document as collateral to ensure safe-keep and return was a suggestion of PRGs.There was a reluctance among carers to initiate success sharing over the community chat section in the mHealth app because of a superstition of 'the evil-eye' among some carers.Nevertheless, we felt the benefits of codesign were substantial.Modifications and adaptations shaped contextually and situationally were informed by feedback from carers, program staff, treating physicians, and nursing staff caring for chronically ill tracheostomized patients in the ICUs.
Plan for future evaluation.We will use a mixed methods approach to assess the fidelity, feasibility, appropriateness, and acceptance of the pilot AIR intervention by the stakeholders.The Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), & Feasibility of Intervention Measure FIM, AIM, IAM framework will be used to evaluate stakeholder perspectives regarding the feasibility, acceptability, and appropriateness of the intervention 35 .This evaluation tool has been chosen for its simplicity of assessment and ability to be conducted via telephone.Essential elements for fidelity are predefined (the proportion of approached patient-carer dyads counselled, consented, and received the components of the intervention).Data are kept on the number of patient-carers approached, proportion consented, and proportion completed each intervention step.Assessment of the quantitate training scores, data on fidelity of the intervention, analysis of case mix, and outcomes for patients included and not included in the project from the existing IRIS registry.
In addition, semi-structured interviews with carers and providers will be analyzed and triangulated with the feedback to explore stakeholder perspectives regarding the project and to identify barriers and facilitators to implementation prior to scaling up.Adherence to AIR will be reported in the results of the ongoing single-arm feasibility study registered prospectively in the Clinical Trials Registry India (CTRI/2020/11/029443 [Registered on: 27/11/2020] Trial Registered Prospectively).

Conclusions
We detail the development of the AIR intervention and describe it in detail.The provision of structured intervention protocols in sufficient detail aids the implementation of complex interventions and reduces research waste, providing tools to maximize protocol fidelity.University of Southampton, Southampton, England, UK Thank you for inviting me to review this manuscript.The authors report the method for developing a home rehabilitation program for tracheostomised patients.The description of the methodology is thorough and detailed.

Data availability
I can see that the authors have used the TIDIER intervention description checklist, however, I would like to see a more detailed description of the M-Health application.The other components are adequately described and would enable replication.
Authors do not report results, which will follow in a separate feasibility and process evaluation report.However, the first paragraph of the discussion refers to increased carer confidence, facilitated home discharge and continuation of support.These statements are not supported by results in the manuscript and should be moderated.
The plan for future evaluation is appropriate to the intervention and consistent with MRC guidance for evaluation of complex healthcare interventions.I look forward to reading the results paper.
Overall, the authors should be applauded for a thorough and well written report of the methods used to develop a complex healthcare intervention.With the two minor revisions requested above this manuscript will help researchers and clinicians to replicate the development of such an intervention.

Is the rationale for developing the new method (or application) clearly explained? Yes
Is the description of the method technically sound?Yes Reviewer Expertise: Critical care recovery.
I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above.I can see that the authors have used the TIDIER intervention description checklist, however, I would like to see a more detailed description of the M-Health application.The other components are adequately described and would enable replication.Answer: We appreciate the interest in the details of the application.In view of the word limit we have added a description and a figure to explain it in greater detail.
Authors do not report results, which will follow in a separate feasibility and process evaluation report.However, the first paragraph of the discussion refers to increased carer confidence, facilitated home discharge and continuation of support.These statements are not supported by results in the manuscript and should be moderated.

Answer:
The observation is correct, thank you for pointing this out.The statements have now been moderated to-"In its mature form, the AIR intervention engages stakeholders from the initiation of patient recruitment to home discharge and follow up in a way that hopes to empower families to care for their tracheostomised bed ridden patients at home, by using the four components of the intervention: the hands-on training for carer confidence, the equipment bank allowing for facilitated home discharge in our economically challenged population, the mHealth app allowing bidirectional communication and home visits for continuation of support." The plan for future evaluation is appropriate to the intervention and consistent with MRC guidance for evaluation of complex healthcare interventions.I look forward to reading the results paper.Answer: Grateful for your comment.We will love for you to review and guide our evaluation manuscript, if possible.
Competing Interests: No competing interests were disclosed.In the last cell of table 1 (line 6) there is an incomplete sentence 2. The authors are to be commended for describing a complex intervention designed for a low research setting which included engagement of patient carers through a partnership approach.I appreciate the importance but also the difficulty of reporting this development work.

Is the description of the method technically sound? Partly
The authors set a clear introduction to the work, describing the need and importance.However I found the reporting confusing in places which might be improved by considering the following comments: It is not always clear whether the authors are reporting the overall design work, the stakeholder engagement process, or the reporting process.For example the methods section refers to 'mixed methods' which appears however to refer to literature sought/used in design, and then mostly describes the participatory design process; the results describe the co-design process and the interventions components; the discussion briefly attends to observations about the co-design process but also the challenges of using the reporting checklist.I think part of the challenge is trying to use the TIDIER checklist to structure a results section which is problematic for narrative flow as it includes items from background, methods and results; more commonly a reporting checklist for any study type would be submitted as a supplementary file with the page reference for where those data are reported, as an aid to ensuring complete reporting. 1.
I note reference to the MRC guidance for designing complex interventions.I suggest that the authors might find O'Cathain's specific guidance on developing complex interventions 1 a more suitable structure for reporting this work, perhaps using the 'actions to consider' and potential outputs to guide how the current report is structured, and then supplying the TIRIER checklist as supplementary material.It might help resolve some of the confusing jumping around (eg reporting checklist item 4 before 3) and the repetition that exists currently between reporting the codesign actions and their findings and then subsequent refinement.A logic model would be a useful addition to tie theory/literature (mentioned briefly at the start of methods but not further articulated) and some of the co-design findings to planned activities and intended outcomes, which is still not well articulated and will be important for informing evaluation of the process 2.
It would be helpful if the final bundle of four interventions (what each looks like, how it Is delivered, who is eligible for them)-could be more clearly articulated in a single part of the results.

3.
The partnership process in this manuscript is variously called experience-based co-design, participatory action research, participatory design and co-design throughout the article.The actual activities of the PRG are not clear to me form text and figure 1 and I am not clear whether the boxes marked 'carer meet' refer to the PRG or ad hoc meetings with carers who were trialling materials.The methods do not fully adhere to EBCD methods, as there is not a clear description of in situ observation of practices nor use of a 'trigger' film highlighting the touchpoints that was used in a combined meeting of patients/carers and providers-carer videos instead are described as part of educational resources.I suggest use of a less specific term for the co-design method throughout the manuscript.

4.
I found it difficult to follow in the results at times what were iterative design steps and what involved actual pilot of the processes and tools in the clinical setting (as there appear to have already been 200 patients enrolled in this new process).This was complicated by inconsistent use of past, present and future tense in the results section.

5.
I suggest that research activities (eg planned feasibility study mentioned under checklist item 11 and research data collection mentioned under item 5) are separated clearly from the intervention design in the results and discussion.

6.
I suggest reframing the discussion to briefly describe the final intervention and how it addresses the problem; compare with other approaches in the literature; discuss the strengths and weaknesses of the development approach, and particularly how generalisable the intervention might be or what local adaptation would be required for others to trial it; and outline plans for locally evaluating the intervention now that it is mature. 7.

Is the rationale for developing the new method (or application) clearly explained? Yes
Is the description of the method technically sound?Yes discussion briefly attends to observations about the co-design process but also the challenges of using the reporting checklist.I think part of the challenge is trying to use the TIDIER checklist to structure a results section which is problematic for narrative flow as it includes items from background, methods and results; more commonly a reporting checklist for any study type would be submitted as a supplementary file with the page reference for where those data are reported, as an aid to ensuring complete reporting.We appreciate the observation by the reviewer, and thank her for the suggestion to use the structure suggested by O' Cathain et al to report the development and description, keeping the Tidier as a supplement.We have restructured the manuscript accordingly.
I note reference to the MRC guidance for designing complex interventions.I suggest that the authors might find O'Cathain's specific guidance on developing complex interventions1 a more suitable structure for reporting this work, perhaps using the 'actions to consider' and potential outputs to guide how the current report is structured, and then supplying the TIRIER checklist as supplementary material.It might help resolve some of the confusing jumping around (eg reporting checklist item 4 before 3) and the repetition that exists currently between reporting the codesign actions and their findings and then subsequent refinement.A logic model would be a useful addition to tie theory/literature (mentioned briefly at the start of methods but not further articulated) and some of the co-design findings to planned activities and intended outcomes, which is still not well articulated and will be important for informing evaluation of the process 1.
We have now edited the methods and results into 'actions' and 'outcomes' framework as suggested.A logic model has also been added now (Figure 3).It would be helpful if the final bundle of four interventions (what each looks like, how it Is delivered, who is eligible for them)-could be more clearly articulated in a single part of the results.

1.
We have now created a separate section titled 'The AIR intervention' which describes the four intervention components separately in greater detail.
The partnership process in this manuscript is variously called experience-based codesign, participatory action research, participatory design and co-design throughout the article.The actual activities of the PRG are not clear to me form text and figure 1 and I am not clear whether the boxes marked 'carer meet' refer to the PRG or ad hoc meetings with carers who were trialling materials.The methods do not fully adhere to EBCD methods, as there is not a clear description of in situ observation of practices nor use of a 'trigger' film highlighting the touchpoints that was used in a combined meeting of patients/carers and providers-carer videos instead are described as part of educational resources.I suggest use of a less specific term for the co-design method throughout the manuscript.

1.
We agree that different terms have been used to describe the partnership process, and this might be a result of the difference in definitions given variously in published articles.However, we are happy to accept the reviewer's suggestion, and have now simplified this by using the term-'codesign' to refer to the partnership process throughout.I found it difficult to follow in the results at times what were iterative design steps and what involved actual pilot of the processes and tools in the clinical setting (as 1. there appear to have already been 200 patients enrolled in this new process).This was complicated by inconsistent use of past, present and future tense in the results section.We apologise for the lack of clarity.We have now specified more clearly that data from the first 70 patients were used to finalise the development of the modules and the pilot testing began thereafter.
I suggest that research activities (eg planned feasibility study mentioned under checklist item 11 and research data collection mentioned under item 5) are separated clearly from the intervention design in the results and discussion. 1.
As suggested, we have now separated the planned feasibility study and research data collection from item 5.from the results.I suggest reframing the discussion to briefly describe the final intervention and how it addresses the problem; compare with other approaches in the literature; discuss the strengths and weaknesses of the development approach, and particularly how generalisable the intervention might be or what local adaptation would be required for others to trial it; and outline plans for locally evaluating the intervention now that it is mature.

1.
Thank you for the suggestion.We have now reframed the discussion as suggested.
Competing Interests: NIL

Figure 4 .
Figure 4. Intervention processes and procedures.RA Research Assistant, CCI Chronically Critically Ill, WG Working Group (including the Treating doctor), CC Core Committee, NT Nurse Trainer, QOL-Quality of Life.
Underlying data Figshare: AIIMS ICU Rehabilitation (AIR): healthcare intervention development and description.Underlying data.https://doi.org/10.6084/m9.figshare.23445329.This project contains the following extended data: -Poster / Infographic for the intervention (for healthcare workers) -Brochure for patients and carers in local language -Training module for trainers and carers -Tool for Assessment of Carer proficiency -Diet charts in local language.Data are available under the terms of the Creative Commons Zero "No rights reserved" data waiver (CC0 1.0 Public domain dedication).

Are sufficient details provided
to allow replication of the method development and its use by others?Yes If any results are presented, are all the source data underlying the results available to ensure full reproducibility?No source data required Are the conclusions about the method and its performance adequately supported by the findings presented in the article?Partly Competing Interests: No competing interests were disclosed.

Reviewer Report 13
April 2024 https://doi.org/10.21956/wellcomeopenres.22855.r77720© 2024 Mudge A. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.Alison M Mudge 1 Faculty of Medicine, The University of Queensland, Herston, Queensland, Australia 2 Faculty of Medicine, The University of Queensland, Herston, Queensland, Australia The manuscript is much improved and I amend my previous assessment to approved.I noted just two typographical errors which you may choose to amend: Three sentences are inadvertently repeated on end page 10/beginning page 11 (subsection "intervention bundles/The M-Health application") 1.

1 Reviewer
Are sufficient details provided to allow replication of the method development and its use by others?PartlyIf any results are presented, are all the source data underlying the results available to ensure full reproducibility?Partly Are the conclusions about the method and its performance adequately supported by the findings presented in the article?Partly Competing Interests: No competing interests were disclosed.Reviewer Expertise: Health services research, implementation of complex healthcare interventions I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard.Version Report 16 November 2023 https://doi.org/10.21956/wellcomeopenres.21425.r68014© 2023 Mudge A. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.Alison M Mudge 1 Faculty of Medicine, The University of Queensland, Herston, Queensland, Australia 2 Faculty of Medicine, The University of Queensland, Herston, Queensland, Australia Re: AIIMS ICU Rehabilitation (AIR): development and description of intervention for home rehabilitation of chronically ill tracheostomized patients using the TIDieR checklist

Are sufficient details provided
to allow replication of the method development and its use by others?Partly If any results are presented, are all the source data underlying the results available to ensure full reproducibility?Partly Are the conclusions about the method and its performance adequately supported by the findings presented in the article?Partly Competing Interests: No competing interests were disclosed.Reviewer Expertise: Health services research, implementation of complex healthcare interventions I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above.